PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS— 510(k) K851355

Name: FDA 510(k) clearance K851355
Creator: U.S. Food and Drug Administration
Published: 1985-04-12

Substantially Equivalent

Intl. Playtex, Inc.

FDA 510(k) clearance K851355 for PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS, Substantially Equivalent on 1985-04-12. Applicant: Intl. Playtex, Inc.. Device class: 2.

Clearance details

Applicant: Intl. Playtex, Inc.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 1985-04-04
Decision date: 1985-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

Download summary PDF View on FDA.gov ↗

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K253719 — Unscented Menstrual Long Applicator Tampon +2 more2025-12-17
K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS2025-10-09
K252613 — Unscented menstrual three-piece applicator tampon2025-09-19
K251033 — Unscented menstrual long applicator tampon +3 more2025-08-13

More clearances from Intl. Playtex, Inc.

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K871197 — PLAYTEX TAMPONS AND DEODORANT TAMPONS1987-05-12
K861738 — PLAYTEX TAMPONS1986-07-22
K854258 — PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA1985-11-21
K852063 — PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS1985-05-22
K851356 — PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS1985-04-12

Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.